To Revisit the Yield of Staging Laparoscopy in Hepatopancreatobiliary Malignancies
This research project, to be conducted at the Institute of Liver & Biliary Sciences, aims to evaluate the effectiveness of staging laparoscopy (SL) in detecting occult metastases in hepatopancreatobiliary (HPB) malignancies in the current era of advanced imaging modalities such as MDCT, MRI, EUS, and PET-CT. While SL is a minimally invasive technique that aids in identifying radiologically undetectable metastases, its utility in routine practice is under scrutiny due to improved imaging accuracy. The study is premised on the hypothesis that the yield of SL is low in the current imaging era, questioning its routine application.
The study uses an ambispective cohort design and includes all patients undergoing SL for HPB malignancies from January 2012 to March 2026 at ILBS, Delhi. The primary objective is to assess the yield of SL, while secondary objectives include evaluating false positives/negatives, the added value of PET-CT over CT, and identifying clinical or radiological predictors of positive SL.
Subgroup analyses will be performed for different HPB cancers including periampullary malignancies, gallbladder cancer, hilarcholangiocarcinoma, intrahepatic cholangiocarcinoma, pancreatic ductal adenocarcinoma, and hepatocellular carcinoma. Data collection includes demographics, tumor markers, imaging findings, SL results, duration, and associated costs.
Findings from this study could inform refined criteria for the selective use of SL, avoiding unnecessary surgeries and optimizing resource utilization. This could lead to evidence-based guidelines for staging practices in HPB cancers, balancing clinical benefits against costs and surgical risks in the context of modern diagnostic capabilities.
Study Overview
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Rahul Shivhare, MS
- Phone Number: 01146300000
- Email: rahulshivhare93@gmail.com
Study Contact Backup
- Name: Ragini Kilambi, Mch
- Phone Number: 01146300000
- Email: ragini.kilambi@gmail.com
Study Locations
-
-
National Capital Territory of Delhi
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New Delhi, National Capital Territory of Delhi, India, 110070
- Recruiting
- Institute of liver and Biliary Sciences
-
Contact:
- Rahul shivhare, MS
- Phone Number: 01143600000
- Email: rahulshivhare93@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
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All patients with suspected HPB malignancies undergoing staging laparoscopy before proceeding to laparotomy.
Pre-op CT scans of cut size less than or equal to 1.5 mm
Exclusion Criteria:
- Patients undergoing staging laparoscopy without intent of curative resection in the same sitting.
- malignancies other than adenocarcinoma
- Final histopathology is benign
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
carcinoma gall bladder
suspected CaGb patients based on preoperative imaging undergoing staging laparoscopy and the final histopathology suggestive of adenocarcinoma of gall bladder
|
NO INTERVENTION AS THIS IS AN OBSERVATIONAL STUDY
|
|
Hepatocellular carcinoma
suspected HCC patients based on preoperative imaging undergoing staging laparoscopy and the final histopathology suggestive of HCC
|
NO INTERVENTION AS THIS IS AN OBSERVATIONAL STUDY
|
|
Perihilar and hilar cholangiocarcinoma
suspected Perihilar and hilar cholangiocarcinoma patients based on preoperative imaging undergoing staging laparoscopy and the final histopathology suggestive of adenocarcinoma
|
NO INTERVENTION AS THIS IS AN OBSERVATIONAL STUDY
|
|
Peri-ampullary Malignancy
suspected Peri-ampullary Malignancy patients based on preoperative imaging undergoing staging laparoscopy and the final histopathology suggestive of adenocarcinoma
|
NO INTERVENTION AS THIS IS AN OBSERVATIONAL STUDY
|
|
Intrahepatic cholangiocarcinoma
suspected Intrahepatic cholangiocarcinoma patients based on preoperative imaging undergoing staging laparoscopy and the final histopathology suggestive of adenocarcinoma
|
NO INTERVENTION AS THIS IS AN OBSERVATIONAL STUDY
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the yield of staging laparoscopy in HPB malignancies
Time Frame: DAY 0
|
proportion of patients with positive staging laparoscopy (Metastatic disease/unresectable) findings leading to abandonement of procedure
|
DAY 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Positive findings on SL leading to abandonment
Time Frame: DAY 0
|
findings like peritoneal/liver/omental nodules which are postive on frozen section proving metastatic disease
|
DAY 0
|
|
False positive findings
Time Frame: DAY 0
|
findings like peritoneal/liver/omental nodules which are negative on frozen section
|
DAY 0
|
|
Additional findings reported on laparotomy after SL
Time Frame: DAY 0
|
finding of nodules/metastatis on laparotomy which are not detected on staging laparoscopy
|
DAY 0
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ILBS-HPBMALIGNANCY-O1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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